A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities



Status:Completed
Conditions:Peripheral Vascular Disease, Women's Studies, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Reproductive
Healthy:No
Age Range:40 - Any
Updated:8/3/2016
Start Date:December 2012
End Date:November 2013

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A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES

This randomized, double-blind, placebo-controlled, parallel group, multicenter study will
evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable
cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive
either aleglitazar 150 mcg orally daily or matching placebo.


Inclusion Criteria:

- Male and female patients with established evidence of stable cardiovascular disease
(CVD) defined as at least one of the following groups of criteria (A or B) A. Age >/=
40 years with history with prior CV event of prior myocardial infarction or prior
ischemic stroke (confirmed by brain imaging study), with onset >/= 3 months prior to
randomization and stable in the Investigator's judgment B. Age >/= 55 years with
evidence of CVD (stable in the Investigator's judgment), defined as at least one of
the following: Coronary disease, cerebrovascular disease or peripheral arterial
disease as defined by protocol

- Patients with glucose abnormalities based on one of the following A-B criteria:

A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment
may include diet alone, or any glucose-lowering therapies except for thiazolidinediones
(TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities

- Optimal management of CV risk factors including hypertension and dyslipidemia as
informed by the best evidence and clinical practice guidelines

Exclusion Criteria:

- Current treatment with a thiazolidinedione (TDZ) or fibrate

- Prior intolerance to a TDZ or fibrate

- Previous participation in a trial with aleglitazar

- Other types of diabetes

- Inadequate liver, hematologic or renal function

- Symptomatic heart failure classified as NYHA class II-IV

- Hospitalization for a primary diagnosis of heart failure in the 12-month period
preceding randomization

- Peripheral edema which in the judgment of the Investigator in believed to be severe
and of cardiac origin

- History of surgical coronary revascularization (CABG) less than 5 years prior to
screening, except in cases of subsequent myocardial infarction

- Currently scheduled for arterial revascularization procedures

- Systemic corticosteroid therapy for > 2 weeks within 3 months prior to screening

- Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ
carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
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